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NCT Number: NCT04205214

A Randomised Control Trial of Integrative Cognitive Behavioural Therapy for Alopecia

This Randomised Control Trial (RCT) aims to test a novel Alopecia-tailored, protocolled, integrative individual psychological intervention offered to patients with enduring Alopecia. The pilot study aims to assess the impact of the intervention on 8 patients, by assessing changes in their psychological and physical symptoms (stress, anxiety, depression, quality of life, scalp hair, and other bio-markers) compared to 7 patients in the wait-list control group.

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Key information

Conditions

Alopecia Alopecia Areata Alopecia universalis Hair Diseases Hypotrichosis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Free Hospital

London, United Kingdom

About this study

Alopecia is a stress-related auto-immune skin condition that results in hair-loss on the scalp and around the body. This pilot RCT aims to test a newly developed Alopecia-specific, psychological intervention with 8 patients diagnosed with enduring Alopecia. The intervention is an Integrative Cognitive Behavioural Therapy, implemented through a protocolled programme entailing 12 weeks of hourly individual sessions. The trial will be delivered at The Dermatology Department at the Royal Free Hospital in Hampstead, London. The pilot study aims to evaluate the impact of the intervention on patients' psychological and physical symptoms (stress, anxiety, depression, quality of life, scalp hair, and other bio-markers) compared to the wait-list control group.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of Alopecia received by medical profession over 1 year prior to beginning trial
  • Fluent in Written and Verbal English

Exclusion criteria

  • Another more dominant skin condition
  • Another more dominant severe and enduring mental illness
  • Women who are pregnant
  • Learning difficulties, brain injuries or dementia
  • Drug and alcohol dependency
  • Received therapy in the last year

Treatment and study plan

Integrative Cognitive Behavioural Therapy

Behavioral

This intervention involves the psychological intervention of Cognitive Behavioural Therapy. This intervention also includes third wave psychological interventions of Mindfulness and Narrative Therapy which has been found to be helpful for people with chronic health conditions and chronic skin conditions.

Primary outcomes

  1. Hospital Anxiety And Depression Scale (HADS)

    Time frame: 12 weeks

    Psychological Measure: Self-reported questionnaire assessing anxiety and depressive symptoms

  2. Perceived Stress Scale (PSS)

    Time frame: 12 weeks

    Psychological Measure: Self-reported questionnaire measuring perceived stress

  3. Dermatology Life Quality Index (DLQI)

    Time frame: 12 weeks

    Psychological Measure: Self-reported questionnaire measuring impact of Alopecia on participants quality of life

  4. Severity of Alopecia Tool (SALT) Scalp Assessment

    Time frame: 12 weeks

    Physical Measure: Percentage of total hair loss

  5. Blood Test

    Time frame: 12 weeks

    Physical Measure: Thyroid Stimulating Hormone Serum (Munit/ L) and Ferritin Serum (Micrograms)

Secondary outcomes

  1. Physical Measures

    Time frame: 12 weeks

    Medical Photography

Sponsors and collaborators

Lead sponsor

City, University of London

Other

Collaborators

  • Royal Free Hospital NHS Foundation Trust

Registry information

Official study title

A Randomised Control Trial of Integrative Cognitive Behavioural Therapy for Alopecia: A Pilot Study

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Dec 19, 2019
Registry last updated
Sep 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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